sop for operation and cleaning of mass mixer

Purpose
1.1 To lay down a procedure for Operation and Cleaning of Mass Mixer.
2.0 Scope
2.1 This SOP is applicable for Operation and Cleaning of Mass Mixer in ABC Pvt. Ltd.
3.0 Responsibility
3.1 Machine Operator To execute the procedure.
Production & QA officer Follow the procedure as per SOP
Head Production Training and Implementation of SOP

4.0 Accountability
4.1 Production Head is accountable for compliance of this SOP.
5.0 Procedure
5.1 Pre-Startup
5.1.1 Check the cleanliness of the room.
5.1.2 Update the status label with details”.
5.1.3 Check the Room temperature, Relative humidity and Differential pressure and record

it in the environmental monitoring format, if it is not within limit inform to the maintenance

and do not proceed till it gets rectified.
5.1.4 Check and ensure the availability of the rinse water/swab analysis report and attach that

in batch manufacturing record.
5.1.5 Check the cleanliness of the Mass Mixer and ensure that the Mass Mixer is free from

remnants of the previous product.
5.1.6 Check the material lying in the room is of the same batch to proceed.
5.1.7 Take the line clearance from QA officer.
5.2 Operation
5.2.1 Switch ON the main electrical connection.
5.2.2 Start the machine for 1-2 minutes, without feeding the material to check the proper working of machine.
5.2.3 Load the sifted materials to the mass mixer and close the top lid. Press MIXER ON, for dry

mixing as per time given in BMR.
5.2.4 Add the Paste gradually and carry out the wet mixing as per Batch Manufacturing Record.
5.2.5 Unload the material in to tray or FBD Bowl after Completion of Wet mixing. Scrap out the adhering

wet mass to the mass mixer with the help of scrapper.
5.2.6 Affix “To be cleaned” label on the machine.
5.2.7 Record the operation in the Equipment Log & respective BMR.
5.3 Cleaning
5.3.1 Type A (Product to product changeover)
5.3.1.1 Update the status label in the area as “UNDER CLEANING”.
5.3.1.2 Switch “OFF” main supply and remove the electrical wire from socket.
5.3.1.3 Lift the lid of mass mixer.
5.3.1.4 Remove the dust particles from inside, outside surface and lid of mass mixer by vacuum cleaner.
5.3.1.5 Clean the mass mixer from inside surface, blades, shaft, outside surface and lid with Raw water.
5.3.1.6 Carry out continuous flushing with Raw water.
5.3.1.7 Ensure that no material is adhered to the corner and edges of the shaft.
5.3.1.8 Remove the water and rinse with purified water and dry it by using air and clean lint free cloth.
5.3.1.9 Assemble the cleaned dismantled parts and update the status board.
5.3.1.10 Record the cleaning details in the Equipment Log.
5.3.1.11 If the Mass Mixer not use within 72 hrs. after cleaning, then reclean the Mass Mixer with purified water before use.
5.3.1.12 After Preventive Maintenance clean the machine with purified water before Use.
5.3.2 Type B (batch to batch changeover)
5.3.2.1 Update the status board of the area “UNDER CLEANING”.
5.3.2.2 Switch “OFF” the control panel and main supply.
5.3.2.3 De-dust the Mass Mixer from outside with the help of vacuum cleaner or lint free cleaned cloth.
5.3.2.4 Record the cleaning operation in the Equipment Log.
5.3.3 Drying
5.3.1 After cleaning of Mass Mixer mop it from inner and outer side and its dismantle accessories with dry lint free cloth.
5.3.2 Ensure the complete dryness of machine and its accessories.
5.3.3 Affix cleaned status label on machine after ensuring complete drying.
5.3.4 Always kept the machine well closed while not in use.
5.5 Training shall be provided to the concerned person.

6.0 References:
In-house
7.0 Attachment
Nil

8.0 Distribution:
8.1 Distribution of the controlled copy of the SOP shall be made by concerned departments.
8.2 Additional copies may be issued for specific purpose.

Revision No.	Supersedes	Effective Date	Details of Reason
01	Nil	28/03/2026	New SOP

sop for operation and cleaning of mass mixer

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